top of page
Home
About
Contact
More
Blog
Glossary
More
Use tab to navigate through the menu items.
Log In
Get Started
The MedTech Collective
Community. Curated.
Glossary of Common Terms
Quality & Regulatory
Gategory
Related Terms
Return To Glossary's Main Navigation
510(k) Exemption
Learn More
ASTM Standards (e.g., ASTM F1980)
Learn More
Anti-Kick Back Statute
Learn More
Audit Trail
Learn More
Biologics License Application (BLA)
Learn More
Business Associate Agreement (BAA)
Learn More
CE Marking
Learn More
Class I Medical Devices
Learn More
Class III Medical Devices
Learn More
Class IIb Medical Devices (EU)
Learn More
Cleanroom Standards (ISO 14644)
Learn More
Confidential Disclosure Agreement
Learn More
Conformity Assessment
Learn More
Data Privacy
Learn More
Declaration of Conformity
Learn More
Device Labeling
Learn More
EU IVDR
Learn More
Economic Operators (in EU MDR)
Learn More
Emergency Use Authorization (EAU)
Learn More
Exempt Devices
Learn More
FDA (Food & Drug Administration)
Learn More
False Claims Act
Learn More
Freedom to Operate (FTO)
Learn More
Global Medical Device Nomenclature (GMDN)
Learn More
Good Distribution Practice (GDP)
Learn More
Good Laboratory Practice (GLP)
Learn More
HIPAA (Health Insurance Portability and Accountability Act)
Learn More
Health Level Seven (HL7)
Learn More
IEC 60601
Learn More
ISO 10993 (Biological Evaluation of Medical Devices)
Learn More
ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice)
Learn More
ISO 14708 (Implantable Medical Devices)
Learn More
ISO 15223 (Medical Device Symbols for Labeling)
Learn More
ISO 20417 (Information to Be Supplied by the Manufacturer of Medical Devices)
Learn More
ISO 407 (Small Medical Gas Cylinders – Valve Connections)
Learn More
ISO 5834 (Implants for Surgery – Ultra-High-Molecular-Weight Polyethylene)
Learn More
ISO 62304 (Medical Device Software – Software Life Cycle Processes)
Learn More
ISO 7199 ( Cardiovascular Implants and Artificial Organs – Blood-Gas Exchangers)
Learn More
ISO 80601 (Medical Electrical Equipment – Particular Requirements for Medical Devices)
Learn More
ISO/TR 24971 (Guidance on the Application of ISO 14971 for Risk Management of Medical Devices)
Learn More
Incident Reporting
Learn More
Intellectual Property (IP)
Learn More
International Organization for Standardization (ISO)
Learn More
Labeling Compliance
Learn More
Legacy Devices
Learn More
Manufacturer's Declaration of Conformity
Learn More
Market Authorization Holder (MAH)
Learn More
Measurement Systems Analysis (MSA)
Learn More
Mock FDA Inspection
Learn More
Non-Conformance
Learn More
Non-Destructive Testing (NDT)
Learn More
Notified Body (NB)
Learn More
On-label Use
Learn More
Post-Market Surveillance (PMS)
Learn More
Pre-Market Notification Submission Process
Learn More
Preventive Maintenance
Learn More
Quality Assurance (QA)
Learn More
Quality Management System (QMS)
Learn More
Quality Metrics
Learn More
Recall
Learn More
Regulatory Pathway
Learn More
Risk Management File (ISO 14971)
Learn More
Root Cause Analysis
Learn More
Significant Risk Device (SR)
Learn More
Supplier Quality Agreement
Learn More
Toxicology Testing
Learn More
Trade Secret
Learn More
Unique Device Identifier (UDI)
Learn More
Validation Protocols
Learn More
eCTD (Electronic Common Technical Document)
Learn More
ANSI/AAMI Standards
Learn More
Adverse Event (AE) Reporting
Learn More
Approval Pathway
Learn More
Authorized Representative (AR)
Learn More
Breakthrough Device Designation
Learn More
CAPA (Corrective & Preventative Action)
Learn More
Calibration Protocols
Learn More
Class II Medical Devices (FDA)
Learn More
Class IIa Medical Devices (EU)
Learn More
Cleanroom Classification
Learn More
Complaint Handling Systems
Learn More
Conformance Testing
Learn More
Data Breach Notification
Learn More
De Novo Classification Request
Learn More
Device Accountability
Learn More
Document Control
Learn More
EU MDR
Learn More
Electronic Records Compliance
Learn More
Equivalence in 510(k) Submissions
Learn More
External Audit
Learn More
FDA Form 483
Learn More
Fast Healthcare Interoperability Resources (FHIR)
Learn More
Global Harmonization Task Force (GHTF)
Learn More
Good Automated Manufacturing Practices (GAMP)
Learn More
Good Documentation Practice
Learn More
Guidance Documents (FDA, ISO, EU)
Learn More
Harm & Hazard Analysis (ISO 14971)
Learn More
High-Risk Devices
Learn More
IEC 62304
Learn More
ISO 13485 (Medical Device Quality Management Systems)
Learn More
ISO 14644 (Cleanrooms and Associated Controlled Environments)
Learn More
ISO 14971 (Risk Management for Medical Devices)
Learn More
ISO 16142 (Essential Principles of Safety and Performance of Medical Devices)
Learn More
ISO 25539 (Cardiovascular Implants – Endovascular Devices)
Learn More
ISO 5832 (Implants for Surgery – Metallic Materials)
Learn More
ISO 60601 (Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance)
Learn More
ISO 7153 (Surgical Instruments – Metallic Materials)
Learn More
ISO 80369 (Small-Bore Connectors for Liquids and Gases in Healthcare Applications)
Learn More
ISO 9001 (Quality Management Systems – Requirements)
Learn More
ISO/TR 80001 (Application of Risk Management to IT Networks Incorporating Medical Devices)
Learn More
Instructions for Use (IFU)
Learn More
Intended Purpose
Learn More
Joint Commission Accreditation
Learn More
Labeling For Investigational Devices
Learn More
Low-Risk Device
Learn More
Market Approval
Learn More
Market Clearance
Learn More
Medical Device Coordination Group (MDCG)
Learn More
New Drug Application (NDA)
Learn More
Non-Conformance Report (NCR)
Learn More
Non-Significant Risk Device (NSR)
Learn More
Novel Device Designation
Learn More
Patent Search
Learn More
Pre-Market Approval (PMA)
Learn More
Predetermined Change Control Plan (PCCP)
Learn More
Protected Health Information (PHI)
Learn More
Quality Inspection
Learn More
Quality Manual
Learn More
Quality Risk Management (QRM)
Learn More
Recall Management
Learn More
Regulatory Submission
Learn More
Risk-Based Monitoring
Learn More
SiMD (Software-in-a-Medical Device)
Learn More
Stark Law
Learn More
Technical File (EU MDR)
Learn More
Traceability
Learn More
Transparency Reporting
Learn More
Validation Master Plan (VMP)
Learn More
Voluntary Recall
Learn More
Return To Glossary's Main Navigation
bottom of page
